Examining Carryover Effect in Patients Treated witH Spinal cOrd Stimulation (ECHO)

Not Applicable

Completed

• Conditions: Spinal Cord Stimulation; Neuralgia
• Interventions: Device: Temporary device deactivation

• Registration Number: NCT03386058
• Lead Sponsor: University of Aarhus

Brief Summary

Spinal cord stimulation is a minimally invasive surgical treatment for severe, chronic, neuropathic pain that is refractory to conventional treatment.

The treatment consists of an electrode implanted in the epidural space of the spinal cord, either via a percutaneous approach (using the so-called percutaneous leads) or via a surgical (hemi-) laminectomy (using the so-called surgical leads or plate leads).

It is a well-known clinical observation that when activating or deactivating SCS stimulation, there is a variable interval before the patient perceives a clinical effect of the change. This variation goes by different names (carryover, echo, after effect, etc.) and might be dependent on the clinical condition and treatment duration. To our knowledge only very little research has been published on the topic of carryover effects; a recent study showed that the interval is highly variable between patients.

While patients may experience immediate pain relief at the onset of SCS treatment, the effect in patients with a long-term SCS treatment history may have different characteristics, possibly due to ongoing changes in the nervous system.

The aim of this pilot study is to lay the foundation for investigating the carryover effects in spinal cord stimulation.

This will be carried out in a mixed population of patients with different indications for SCS, and with different treatment durations.

Patients will be asked to deactivate their device via their remote control or with a magnet in a standardized fashion.

They will be asked to reactivate the device when specific parameters have been met, and the time is recorded.

Detailed Description

In the post-hoc analysis the carryover and reverse carryover effect will be analyzed and correlated to a number of parameters including, but not limited to: Indication, treatment duration, symptom duration, preoperative pain score, stimulation paradigm, gender, age.

Data will be collected and stored using a dedicated REDCap database under the auspices of Aarhus University.

Study Timeline

• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-29
• Study Start: 2018-01-31
• Status Verified: 2020-11
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Last Update Submitted: 2021-05-12
• Last Update Posted: 2021-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• patient age minimum 18 years
• signed informed consent
• implanted with full SCS system for neuropathic pain
• SCS treatment duration minimum 6 months before inclusion
• maximum pain score 7 or less on a 0-10 NRS at the area of pain treated with SCS during the last 48 hours before study-related deactivation of the device

Exclusion Criteria

• any surgical SCS lead revision for the last 6 months before inclusion
• any changes in the programming patterns of the device (except patient-controlled changes in amplitude) for a minimum of 30 days before the study-related deactivation of the device
• any other ongoing neuromodulatory treatment (PNS, TENS, etc.)
• any other neuromodulatory treatment with lasting effect (RFA, sympathectomy, infiltration anesthesia, nerve blockade) within the last 60 days
• any changes in analgetic medication within the last 30 days (pn. dosings are allowed)

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Temporary device deactivation	Temporary device deactivation

Primary Outcome Measures

Name	Time	Method
Carryover/echo effect: Time from deactivation of device to cessation of treatment affect	Up to one week (may be repeated)	Time from deactivation of device to cessation of treatment affect

Secondary Outcome Measures

Name	Time	Method
Reverse carryover/echo effect: Time from reactivation of device to full reestablishment of treatment effect	Up to one week (may be repeated)	Time from reactivation of device to full reestablishment of treatment effect

Trial Locations

Locations (10)

Diakovera Friederikenstift; 🇩🇪 Hannover, Germany

Medisch Spectrum Twente; 🇳🇱 Enschede, Overijssel, Netherlands

Sunderby Hospital; 🇸🇪 Luleå, Sweden

Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden

AZ Delta Roeselare/Menen/Torhout; 🇧🇪 Roeselare, Belgium

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands

CHU de Québec - Université Laval; 🇨🇦 Quebec City, Quebec, Canada

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark